Revance Therapeutics Inc (NASDAQ:RVNC)

Discussion in 'Men's Economics' started by Michael Scally MD, Mar 6, 2016.

  1. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Revance Therapeutics Inc. (NASDAQ:RVNC)
    Revance Therapeutics

    GF: Revance Therapeutics Inc: NASDAQ:RVNC quotes & news - Google Finance

    Revance Therapeutics, Inc. is a clinical-stage specialty biopharmaceutical company. The Company is focused on the development, manufacturing and commercialization of botulinum toxin products for multiple aesthetic and therapeutic indications. Its TransMTS technology enables delivery of botulinum toxin type A through two dose formulations, topical product candidate RT001 and injectable product candidate RT002. RT001 is a non-injectable dose form. RT001 is being studied for aesthetic indications, such as crow's feet lines (wrinkles around the eyes) and therapeutic indications, such as hyperhidrosis (excessive sweating). It is in a Phase III development program of RT001 in North America for the treatment of crow's feet lines. RT002 is an injectable formulation of botulinum toxin designed to be targeted and longer lasting. RT002 is being studied for aesthetic indications, such as glabellar (frown) lines and therapeutic uses, such as muscle movement disorders.
     
  2. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Revance Releases Fourth Quarter and Full Year 2015 Results
    Revance Releases Fourth Quarter and Full Year 2015 Results (NASDAQ:RVNC)

    NEWARK, Calif., March 02, 2016 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc.(NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, announced today results for the fourth quarter and full year ended December 31, 2015 and provided its 2016 financial outlook.

    Recent Highlights and Upcoming Milestones
    • Clinical Development - DaxibotulinumtoxinA Topical Gel (RT001)
      • Continued active enrollment in REALISE 1, a Phase 3 trial for patients with moderate to severe lateral canthal lines (crow's feet). Revance plans to release 28-day top-line results from this Phase 3 trial by the end of the second quarter of 2016.
      • Announced positive interim results from a Phase 2 trial for axillary hyperhidrosis inDecember 2015, showing measurable reduction in excessive underarm sweating following a single application at the time of treatment. Revance expects to initiate an additional, larger Phase 2 hyperhidrosis trial in the second half of 2016.
    • Clinical Development - DaxibotulinumtoxinA for Injection (RT002)
      • Reported positive top-line interim data from BELMONT Phase 2 Active Comparator Trial of RT002 injectable for the treatment of glabellar (frown) lines in October 2015 and have begun preparing for an End-of-Phase 2 meeting with the U.S. Food and Drug Administration planned for the first half of 2016. Revance expects to initiate a Phase 3 clinical program in the second half of 2016.
      • Completed enrollment in first cohort of the Phase 2 dose-escalating clinical trial for the treatment of cervical dystonia. Revance expects to report interim results in the first half of 2016.
    • Appointed Abhay Joshi, PhD, a seasoned executive with global experience in neurotoxins, biopharmaceuticals, and medical devices, as Chief Operating Officer.

    "With positive clinical trial results reported for both RT001 topical and RT002 injectable in 2015, we were able to demonstrate the viability of our two neurotoxin drug candidates, while simultaneously establishing a foundation of financial and operational stability as we move closer to commercialization," said Dan Browne, President and Chief Executive Officer of Revance. "We currently have four active clinical development programs well underway, targeting both aesthetic and therapeutic indications, with many more opportunities on the horizon as we work to establish a powerful new botulinum toxin franchise. The $3 billion neurotoxin market continues to expand, with a growing number of physicians and patients looking forward to the first differentiated botulinum toxin to be introduced in nearly 30 years. Revance is building a reputation for advancing drug delivery by fueling innovations we believe can have a lasting impact on people's lives."

    Summary Financial Results

    Research and development expenses for the fourth quarter and full year ended December 31, 2015 were $15.0 million and $47.5 million, respectively, compared to $9.1 million and $33.4 million for the same periods in 2014, respectively. The increase in research and development expenses is primarily attributable to increased personnel costs and expenditures related to our ongoing clinical trials.

    General and administrative expenses for the fourth quarter and full year ended December 31, 2015 were $6.9 million and $25.1 million, respectively, compared to $4.8 million and $19.0 millionfor the same periods in 2014, respectively. The increase in general and administrative expenses is primarily attributable to increased personnel costs, legal matters, and administrative activities.

    Total operating expenses for the fourth quarter and full year ended December 31, 2015 were$21.9 million and $72.6 million, respectively, compared to $13.9 million and $52.4 million for the same periods in 2014, respectively. Stock-based compensation for the fourth quarter and full year ended December 31, 2015 was $5.1 million and $12.4 million, respectively. When excluding depreciation and stock-based compensation, total operating expenses for the fourth quarter and full year ended December 31, 2015 were $16.4 million and $58.2 million, respectively.

    Net loss for the fourth quarter and full year ended December 31, 2015 was $22.1 million and$73.5 million, respectively, compared to $14.2 million and $62.9 million for the same periods in 2014, respectively. Upon completion of the IPO in February 2014, Revance recorded non-cash interest expense, including loss on extinguishment, of $9.6 million in connection with the settlement of previously outstanding convertible notes.

    Cash and investments as of December 31, 2015 were $254.1 million.

    2016 Financial Outlook
    Revance expects its 2016 non-GAAP operating expense to be in the range of $95 to $105 million, excluding depreciation of $2 to $3 million and estimated stock-based compensation of $15 to $17 million. The company expects its cash burn for 2016 to be in the range of $105 to $115 million. Revance anticipates 2016 non-GAAP research and development expense to be in the range of $72to $78 million, excluding depreciation of $2 to $3 million and estimated stock-based compensation of $8 to $9 million.

    For modeling purposes and assuming no material issuances of equity, we expect 2016 weighted average number of shares outstanding will be approximately 28 to 29 million.
     
  3. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Revance Announces Late-Breaking Podium Presentation of Positive 6-Month Duration Results for BELMONT Phase 2 Active Comparator Study of Injectable RT002 at the 74th Annual Meeting of the American Academy of Dermatology
    Revance Announces Late-Breaking Podium Presentation of Positive 6-Month Duration Results for BELMONT Phase 2 Active Comparator Study of Injectable RT002 at the 74th Annual Meeting of the American Academy of Dermatology (NASDAQ:RVNC)

    NEWARK, Calif., March 05, 2016 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that clinical results from the company's BELMONT Phase 2 active comparator study of DaxibotulinumtoxinA for Injection (RT002) were reported in a podium presentation at the American Academy of Dermatology (AAD) annual meeting, which is being held in Washington, DC, March 4-8, 2016. Confirming interim clinical results previously reported in October 2015, all three study dose levels of RT002 achieved the Phase 2 study's primary efficacy measurement demonstrating at least 1-point improvement in frown lines based on the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) scale at 4 weeks. This measurement showed a statistically significantly greater response as compared to placebo for each dose level of RT002 (100% investigator-determined response for all three RT002 dose levels vs. 3% response for placebo). In addition, Revance's study demonstrated a 6-month median duration of effect for RT002 based upon at least 1-point improvement in glabellar lines at maximum frown on the IGA-FWS scale.

    • For the mid-dose level of RT002 Injectable 40U, the duration of effect was statistically significantly greater (23.6 weeks) compared to BOTOX® Cosmetic (BOTOX® 20U) (18.8 weeks; p=0.02). RT002 40U is the dose Revance intends to bring forward in Phase 3 clinical studies, which are expected to commence in the second half of 2016.
    • For RT002 Injectable 40U, investigator assessment of None or Mild wrinkles was statistically superior at the majority of time points when compared to BOTOX® Cosmetic. As an example, at 6 months, 31% of subjects receiving RT002 40U maintained None or Mild wrinkles compared to 12% receiving BOTOX® (p < 0.05).
    Across all cohorts, RT002 appeared to be generally safe and well-tolerated. Adverse events were predominantly localized, transient, and mild. There were no serious adverse events or evidence of any systemic exposure at any of the three doses evaluated.

    Also covered within the presentation was a separate study investigating the impact of dosing of BOTOX® Cosmetic on duration of effect. This prior study showed that increased dosing did not result in meaningfully longer duration, an important finding underscoring the need for an alternative, longer-duration treatment.
     
  4. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Plastic surgery is surging in America — the trends in six simple charts
    Plastic surgery is surging in America — the trends in six simple charts

    1. The number of cosmetic procedures performed in the United States jumped 115 percent from 2000 to 2015.

    2. But the types of procedures being performed is changing. Most of the growth has been in minimally invasive cosmetic procedures. Below is a look at the top five in this category.
     
  5. Prairie Boy

    Prairie Boy Member

    So what your saying is....this is prob worth investing in
     
    Michael Scally MD likes this.
  6. Michael Scally MD

    Michael Scally MD Doctor of Medicine

    Revance Expands Botulinum Toxin Assets by Acquiring Intellectual Property (IP) Portfolio
    Revance Expands Botulinum Toxin Assets by Acquiring Intellectual Property (IP) Portfolio

    NEWARK, Calif., June 02, 2016 (GLOBE NEWSWIRE) -- Revance Therapeutics, Inc. (RVNC), a biotechnology company developing botulinum toxin products for use in aesthetic and therapeutic indications, today announced that it expanded its botulinum toxin-related assets by acquiring a portfolio of botulinum toxin-related patents and patent applications. The portfolio, acquired from Botulinum Toxin Research Associates, Inc. (BTRX), of Quincy Massachusetts, covers novel formulations and diverse therapeutic indications, including inflammation, pain, neurological and mood/depression. With the acquisition of more than 70 additional patents and patent applications, Revance’s patent portfolio now exceeds 330, and is one of the largest patent portfolios in the neuromodulation field. Terms of the acquisition include a $2 million upfront payment to BTRX, plus potential milestone payments on future sales and other clinical and regulatory events.